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Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Diakonhjemmet Hospital
Sponsor:
Information provided by (Responsible Party):
Kiarash Tazmini, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier:
NCT01818583
First received: March 22, 2013
Last updated: December 24, 2016
Last verified: December 2016

March 22, 2013
December 24, 2016
March 2013
December 2017   (Final data collection date for primary outcome measure)
Cardioversion (time and percentage) [ Time Frame: 24 hours ]
Same as current
Complete list of historical versions of study NCT01818583 on ClinicalTrials.gov Archive Site
Atrial fibrillation at 3 months follow up visit and during 72 hours ECG-monitoring period. [ Time Frame: At about 3 months follow up, plus additional 3 days ECG-monitoring ]
The patients will be followed up with a resting ECG about three months after study intervention, and subsequently on-demand ECG will be monitored for 72 hours.
Atrial fibrillation at 3 months follow up visit and during 72 hours ECG-monitoring period. [ Time Frame: At 3 months follow up, plus additional 3 days ECG-monitoring ]
The patients will be followed up with a resting ECG three months after study intervention, and subsequently on-demand ECG will be monitored for 72 hours.
Adverse events [ Time Frame: During time of infusion ]
Same as current
 
Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter
Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter

Atrial fibrillation is a condition in which the heart's upper chambers, the atria, contract at an abnormally rapid rate. It is a common type of arrhythmia, and occurs in 1-2% of the general population. The prevalence of atrial fibrillation increases with age. Between 50 and 70% of patients with atrial fibrillation lasting <48 hours spontaneously convert to normal sinus rhythm, and drug therapy increases the likelihood of conversion to sinus rhythm. Another treatment option for conversion of atrial fibrillation and atrial flutter is electrical conversion. This is an effective treatment but requires anesthesia.

Current treatment strategy for medical conversion of atrial fibrillation and atrial flutter is to employ drugs that affect ion channel activity in atrial cardiomyocytes. However, such converting drugs all have potentially serious side effects and are expensive. Potassium, sodium, calcium, and magnesium molecules are the most important ions causing electric current in the heart tissue. Our hypothesis is that hypokalemia promotes atrial fibrillation/atrial flutter by a direct effect on cardiomyocytes. Accordingly, we also hypothesize that potassium infusion may convert atrial fibrillation/atrial flutter to normal sinus rhythm. If so, this would be an inexpensive treatment with potentially very few side effects.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Atrial Flutter
  • Drug: Potassium chloride
  • Drug: Glucose 50 MG/ML
  • Experimental: Potassium
    Potassium chloride infusion at a rate of 15 mmol/h (60 mmol KCl in 1000 ml of 5% glucose with a concentration of 0.05 mmol/mL, flow rate 265 mL/h). If the serum Mg ≤0.8 mmol/L, MgSO4 infusion (0.5 mmol/kg/24 hours in 1000 mL NaCl 0.9% corresponding to an infusion rate of approximately 42 mL/hour) will also be administered.
    Intervention: Drug: Potassium chloride
  • Placebo Comparator: Placebo
    5% glucose (flow rate 265 ml/h) as placebo infusion.
    Intervention: Drug: Glucose 50 MG/ML
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
March 2018
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with paroxysmal atrial fibrillation/atrial flutter with duration <48 hours
  • Plasma potassium ≤4,0 mmol/L.
  • Age ≥ 18 år

Exclusion Criteria:

  • Plasma potassium > 4,0 mmol/L
  • eGFR <30 mL/min
  • Patients on antiarrhythmic therapy (flecainid, amiodarone, dronedarone or sotalol)
  • Pregnancy
  • Breast feeding
  • Patients participating in a clinical trial during the last six months
  • Addison disease, adynamia episodic hereditary, or Sickle cell anemia
  • Metabolic acidosis, pH < 7,2
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Erik Øie, MD, PhD +47-22454055 erik.oie@diakonsyk.no
Contact: Kiarash Tazmini, MD +47-22451500 kiarash.tazmini@diakonsyk.no
Norway
 
 
NCT01818583
AK-01
Yes
Not Provided
No
Not Provided
Kiarash Tazmini, Diakonhjemmet Hospital
Diakonhjemmet Hospital
Not Provided
Study Director: Erik Øie, MD, PhD Diakonhjemmet Hospital
Diakonhjemmet Hospital
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP